Lilly Reaches Settlement Agreement in U.S. Cialis Patent Litigation

Cialis exclusivity is now expected to end at the earliest on September 27, 2018

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Jul 12, 2017, 10:00 ET

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

INDIANAPOLIS, July 12, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis^® (tadalafil) unit dose patent. This patent was previously set to expire on April 26, 2020. As part of the agreement, Cialis exclusivity is now expected to end at the earliest on September 27, 2018.

"The unit dose patent for Cialis is valid and infringed by companies seeking to market a generic version of Cialis. This is a royalty-bearing license agreement that provides us with more certainty regarding our U.S. exclusivity," said Michael J. Harrington, senior vice president and general counsel for Lilly. "Protection of intellectual property and the assurance of market exclusivity are extremely important to Lilly as we work to support the development of the next generation of innovative medicines."

Patent expiration for Adcirca (tadalafil) is still expected on November 21, 2017, or on May 21, 2018, if the U.S. Food and Drug Administration grants the company's application for pediatric exclusivity.

There will be no change to the company's 2017 financial guidance or mid-term expectations through the remainder of the decade as a result of this settlement.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels. C-LLY

This release contains forward-looking statements regarding Cialis patent litigation and related settlement. There can be no guarantees as to the outcome and results of the settlement. These statements are based on management's current expectations, but actual results may differ materially. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission.